Quality Specialist Resume Sample
Laila Graham
354 Becker Spur,
Dallas,
TX
+1 (555) 249 0331
Work Experience
Quality Specialist
01/2016
-
PRESENT
Los Angeles, CA
- Provide reliable and timely assessment of the level of compliance of products against external and internal requirements
- Execute audits as per approved plan
- Report and investigate any product non-conformance
- Act as single point of contact with third party manufacturers for any quality and compliance troubleshooting on Coty products
- Act as Manufacturing Tech Support (MTS) and support the TPM batch industrialization process and piloting at TPM
- Conduct Industrial Chemistry related testing and liaise between R&D and Quality Department
- Support the DCs providing technical information required by authorities
- Audit processes to ensure quality standards are being met
- Work on quality improvement projects, launches, etc. as needed
Quality Specialist
04/2009
-
08/2015
Phoenix, AZ
- Provide guidance on quality issues with production, component suppliers and TPM’s
- Responsible testing of consumer complaint samples submitted to the laboratory
- Maintains a clear understanding and working knowledge of GMP requirements, Safety requirements, and SOP’s. Adheres to and enforces those policies within the team
- To Improve Quality. RFT (Right First Time)
- To improve Quality – PPM (Parts per Million)
- QC Release Strategy (3-5 day release)
- Good knowledge and application of MS-Office suite
- Work in a very fast pace environment
Education
University of Wisconsin-Richland
2004 - 2009
Bachelor's Degree in Engineering
Professional Skills
- Strong interpersonal skills with proven ability to influence effectively at all levels of the organization
- Strong analytical skills and skills in data extraction and analysis
- Good written and verbal commination skills including negotiating and relationship management skills
- Proven record of prioritizing effectively and handle shifting priorities Ability to work across multiple systems and platforms
- Interpersonal skills and professional skills to interact with external interfaces while representing Shire
- Excellent written and oral communication skills, and a strong track record of working cross functionally
- Strong communication skills-capable of communicating effectively in both written and oral formats
How to write Quality Specialist Resume
Quality Specialist role is responsible for interpersonal, computer, analytical, microsoft, organizational, english, analysis, software, organization, technical.
To write great resume for quality specialist job, your resume must include:
- Your contact information
- Work experience
- Education
- Skill listing
Contact Information For Quality Specialist Resume
The section contact information is important in your quality specialist resume. The recruiter has to be able to contact you ASAP if they like to offer you the job. This is why you need to provide your:
- First and last name
- Telephone number
Work Experience in Your Quality Specialist Resume
The section work experience is an essential part of your quality specialist resume. It’s the one thing the recruiter really cares about and pays the most attention to.
This section, however, is not just a list of your previous quality specialist responsibilities. It's meant to present you as a wholesome candidate by showcasing your relevant accomplishments and should be tailored specifically to the particular quality specialist position you're applying to.
The work experience section should be the detailed summary of your latest 3 or 4 positions.
Representative Quality Specialist resume experience can include:
- Strong communication and collaboration skills, as well as the ability to work effectively with minimal supervision
- Proven skills to provide effective quality training
- Solid organizational, communication, and presentation skills. Knowledge of quality assurance is essential, including document control experience
- Demonstrating solid Java software development and coding skills and knowledge of BDD Automation testing frameworks
- Strong technical writing skills including flowcharting and graphs
- Strong skills working with personal computers and software applications (e.g. word processing, spreadsheet, call recording software, screen capture, etc.)
Education on a Quality Specialist Resume
Make sure to make education a priority on your quality specialist resume. If you’ve been working for a few years and have a few solid positions to show, put your education after your quality specialist experience. For example, if you have a Ph.D in Neuroscience and a Master's in the same sphere, just list your Ph.D. Besides the doctorate, Master’s degrees go next, followed by Bachelor’s and finally, Associate’s degree.
Additional details to include:
- School you graduated from
- Major/ minor
- Year of graduation
- Location of school
These are the four additional pieces of information you should mention when listing your education on your resume.
Professional Skills in Quality Specialist Resume
When listing skills on your quality specialist resume, remember always to be honest about your level of ability. Include the Skills section after experience.
Present the most important skills in your resume, there's a list of typical quality specialist skills:
- Good skills at alpha and numeric sequencing and filing with good proofreading/editing skills
- Good oral and written communication skills, i.e. effective presentation of concepts and ideas, as well as interpersonal and conflict resolution skills
- Excellent written and verbal communication skills, as well as good facilitation and presentation skills
- Demonstrated skills in adaptability, team working, and interpersonal relationships are required in order to effectively perform this job function
- Excellent verbal communication skills and technical writing skills
- High standard of oral and written communication skills and interpersonal skills
List of Typical Experience For a Quality Specialist Resume
1
Experience For Quality Specialist Resume
- Strong critical reasoning, decision-making and problem solving skills to analyze situations
- Excellent Problem Solving/troubleshooting skills and attention to detail
- Strong programming skills with working knowledge of data structures and algorithms
- Demonstrated ability to effectively communicate software defects
- Strong interpersonal skills to deal with sensitive issues
- Excellent oral, written & analytical skills and commitment to continuous quality improvement
2
Experience For Quality Specialist Resume
- Strong desire to learn new skills and to teach others
- Strong computer, scientific, and organizational skills; type at least 40+WPM
- Excellent analytical skills for trending quality data
- Strong customer service / field service skills including both
- Good communication, interpersonal skills and ability to work across teams
- Proven working experience in technical and process documentation writing
- Communication, Oral- Ability to communicate effectively with others using the spoken word
3
Experience For Quality Specialist Resume
- Works effectively in an environment of culture change by setting an example for FSMS compliance in the plant
- Experience with cGMP (current Good Manufacturing Practice) is essential
- Excellent communication and reporting skill
- Skills in quality control and calibration, business process modelling
- Assist with QA Specialists in validation and approval of cGMP product, lot consolidations, segregations and re-classes
4
Experience For Quality Specialist Resume
- Intermediate computer skills with MS Office Products
- 4) Effectively communicates (written and verbal) with colleagues at most levels of the organization to achieve timelines for project completion
- Experience with HERE or combination of equivalent and relevant outside experience
- Work effectively with all levels of management to ensure CAPA action plans can be supported and that costs/resources needed to implement the plan are available
- Auditing of operating activities in all areas; making recommendations for improvements, developing action plans, and following up to ensure effectiveness
- Auditing background: Experience internal auditing and supplier auditing
- Releasing “Quarantined” product into good upon the receipt of documentation from QC and Manufacturing
- Training background: Experience with development and administration of GMP training
5
Experience For Quality Specialist Resume
- Assigning effective dates and advising Divisions of changes to documents
- Working knowledge of or experience with the development, utilization and/or sharing of the use of specialized computer database software
- Working experience in a similar position for the medical devices / pharma is mandatory
- Experience implementing, maintaining and improving quality systems, including SOP writing
- Apply sound, systematic problem-solving methodologies in identifying, prioritizing, communicating, and resolving quality issues through the NCEP/CAPA process
- Experience in black-box and grey-box testing, including automation using Selenium and end-to-end testing
6
Experience For Quality Specialist Resume
- Experience utilizing and following detailed work instructions, reading and interpreting blueprints, drawings, or specifications.
- Experience with tracking, reporting, gathering and analyzing data to produce a clear and concise message
- Experience using technologies for detecting and tracking software defects
- Oversees the first article inspection process. Assigns and prioritizes inspections in accordance with manufacturing, planning and engineering requirements
- Maintain systems for checking, validating and verifying process compliance
- Some quality experience directly supporting manufacturing, service, or engineering
7
Experience For Quality Specialist Resume
- Experience defining Review/Witness/Hold points for SQS inspection plans, monitoring SQS reports, and responding to quality issues when discovered
- Experience in special processes related to manufacturing (Welding,NDE, Heat Treatment,& Coating)
- Oversee monitoring, verification and validation activities to ensure that all products leaving the facility meet Food Safety and Quality Standards
- Strong background in the interpretation of engineering drawings / specifications, manufacturing processes & Assembly Drawings
- Conducts daily routine sample analyses using lab techniques and other instrumentation following Good Laboratory
8
Experience For Quality Specialist Resume
- Conducts daily routine sample analyses using lab techniques and other instrumentation following Good Laboratory Practices
- Support swabbing process for line monitoring or equipment validation
- Working experience in the Quality Department within medical device, aerospace, or similarly regulated manufacturing environment
- Experience of working on projects and organising workload
- Manage the internal audit process including audit action plan tracking and effectiveness check
- Experience working with electronic document management systems (eDMS) and/or electronic learning management systems (eLMS)
- Experience triaging/investigating product complaints in the pharmaceutical industry (2+ years preferably)
9
Experience For Quality Specialist Resume
- Experience in leading and facilitating continuous improvement projects
- Skilled in conducting laboratory analysis using wide array of analytical tools
- Conflict resolution, Problem Solving, Communications, Time Management, Goal- Priority Setting
- Familiar with metal fabrication, metal finishing processes, Plastic/silicon molding, Soft goods etc
- Experience reading and interpreting design drawings and CAD models
- Possess working knowledge of computer software applications along with strong record keeping abilities
- Experience in developing, implementation and maintenance of food quality management and auditing
- Experience writing/reviewing SOPs
- Three years progressive experience working in a Claims/M&B/Service environment/Quality Auditing within Health Plan or related field
10
Experience For Quality Specialist Resume
- Hands-on experience with developing test automation scripts using Selenium /Vyper (mandatory)
- Experience in other Continuous Improvement methodologies (i.e. Lean Manufacturing, Value Stream Mapping, Kaizen) highly desirable
- Experience setting up CI processes using tools like Jenkins, GitLab etc
- Demonstrates knowledge of operating procedures and expertise in auditing and compliance area
- Experience working within and complying with FDA, EMEA medical device regulations and ISO 9001:2008 certification programs
- Experience working in a Pharmaceutical/Aseptic Manufacturing Environment
List of Typical Skills For a Quality Specialist Resume
1
Skills For Quality Specialist Resume
- Strong written and oral communication skills, negotiation skills
- Skill set and experience in leading small to larger scale improvement projects (project management and people management skills
- Demonstrated organizational, problem solving, troubleshooting and interpersonal skills
- Good project management skills, including the identification and scheduling of project deliverables, milestones, tasks, and deadlines
- Excellent facilitation, teaching and coaching skills required, as
- Proven analytical and problem solving and critical thinking skills
- Prior experience working in an FDA regulated environment and a thorough understanding of good documentation practices
- Excellent critical thinking and problem-solving skills with high attention to detail to capably gather and analyze data and draw well-reasoned conclusions
2
Skills For Quality Specialist Resume
- Strong Planning, Organizing and Customer focused skills
- Strong problem-solving skills focus on hands on approach
- Excellent IT, communication and interpersonal skills using current office technologies
- Strong knowledge of Order Processing skills
- Excellent problem solving and analytical skills/ability to exercise independent judgement
- Excellent telephone skills including the ability to handle dissatisfied customers in a professional and tactful manner
- Communication skills and experience in moderating
- Knowledgeable in personal computers, spreadsheets and word processing as well as good written and verbal communication skills
- Excellent interpersonal skills in dealing with internal and external customers
3
Skills For Quality Specialist Resume
- Excellent analytical skills and ability to synthesize trending data into meaningful information for the organization
- Works well independently and with excellent problem solving skills
- Proactive approach and strong critical thinking skills
- Strong analytical and problem solving skills to rapidly determine root cause are required
- Excellent knowledge of local and international Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP)
- Strong interpersonal, communication, coaching and conflict management skills
- Work autonomously and effectively under pressure, manage conflicting priorities
- Have excellent communication and networking skills
- Strong writing skills with clear and concise communication capability
4
Skills For Quality Specialist Resume
- Strong project management skills with the ability to drive development projects across the organisation (external key suppliers)
- Two (2) or more years of experience using MS Office products, with intermediate Excel skills
- Related experience requiring the utiliation of computer skills
- To lead in the tracking of validation activities as per the validation plan and support in the validation steering committee quarterly update
- Basic but solid Microsoft suite skill and experience
- PC knowledge and spreadsheet applications, with strong Excel skills
5
Skills For Quality Specialist Resume
- Solid presentation skills with ability to present technical information and concepts in order to initiate change and drive initiatives across several locations
- Two years of quality (technical/craftsmen background) experience, including technical skills needed for local article inspections
- Excellent verbal/written communication skills are essential in this role
- Independent person with excellent organization skills
- Excellent written and spoken skills with an ability to compose grammatically correct, concise and accurate written responses
- Excellent written and spoken Mandarin and English skills with an ability to compose grammatically correct, concise and accurate written responses
- Strong computer skills in Microsoft Office (Word and Excel)
- Excellent communication skills in German and English, written and spoken
6
Skills For Quality Specialist Resume
- Excellent written and oral communication skills. Ability to organize and draft standard operating procedures
- Organized with excellent time management skills to meet multiple onjectives under shift constraints
- Excellent organizational skills and ability to review processes or procedures
- Produce and interpret data with strong technical, analytical and research skills
- Detail oriented with effective use of time management and organizational skills
7
Skills For Quality Specialist Resume
- Experience of office packages and general computer skills
- Excellent written and verbal communication skills regarding story pointing/estimation, defects reported, test results and status
- Good communication, team management and cross functional skills are required
- Excellent organizational, interpersonal, and technical skills
- Skilled computer skills (MS Office))
- Possess strong written and verbal communication skills as well as the ability to work in a team environment
- Excellent computer systems and MS Office skills with working knowledge of computer related databases
8
Skills For Quality Specialist Resume
- Strong analytical skills and knowledge of quality systems
- Good Analytical Chemistry skills
- Proven communication skills with ability to flex styles to differing individual needs
- Receiving inspection experience with demonstrated knowledge and proven success as a mechanical inspector
- Manufacturing related experience in some of the following areas: sterile, liquid, solids or API’s
- Experience writing and reviewing governing documents particularly in a validation and/or calibration environment
- Provide back-up support including calibration & validation, material review, returned goods handling, handling of customer complaints and document control
- Experience with Document Control. Experience in writing and controlling documents required
9
Skills For Quality Specialist Resume
- Intermediate+ Microsoft Office skills, including Microsoft Excel (manipulating data, vLookups, etc.)
- Analytical Skills- Ability to use thinking and reasoning to solve a problem
- Experience working in a clinical laboratory and have technical experience
- Computer skills: Microsoft Office Suite, Visio (flowcharting), SAP, SharePoint, Minitab
- Eagerness to learn new skills and adapt to a changing environment
- Experience and working knowledge of computer systems and software with strong knowledge of Excel
- Phone skills required for communicating to end customers on a daily basis
- Min 3-5 Years biological experience -Regulatory / Technical / QA experience in biological research , development and / or manufacturing
- Proficiency in oral and written communication, change management, facilitation and coaching skills
10
Skills For Quality Specialist Resume
- Experience in working in sustainable Quality System, preferably ISO 13485, QSR or Pharma experience is also appreciated
- Demonstrate a full understanding of basic cGMP expectations; set a good example in observance of cGMP policies
- Effectively collaborate with stakeholders across the organization to promote quality and standardization and making sure the customers get the right quality
- Detail oriented, problem solving and coordination skills
- PC skills (MS Office, accounting software)
List of Typical Responsibilities For a Quality Specialist Resume
1
Responsibilities For Quality Specialist Resume
- Exceptional organizational skills; ability to manage multiple tasks and prioritize effectively
- Project Management Skills (organization skills / follow-up / communication / status updates)
- Manage multiple and varied tasks with enthusiasm, and prioritize workload with attention to detail and strong organizational skills
- Strong oral and written communications skills with ability to prioritize tasks and efficiently manage time
- Solid organization, problem-solving, decision-making, judgment, leadership, and team-oriented skills are essential to manage multiple projects
- Able to effectively organize and prioritize multiple tasks and work with engineering and manufacturing employees
2
Responsibilities For Quality Specialist Resume
- Good communication skills and accuracy in performing tasks
- Excellent communication (written and oral), presentation and interpersonal skills in both English and French
- Strong organizational skills, ability to follow things through
- Experience working effectively project teams agile delivery environment
- Strong organizational and communication skills, both written and verbal, are critical
- Strong analytical skills to challenge complexity and drive for simplicity
3
Responsibilities For Quality Specialist Resume
- Strong alphanumeric data entry skills, both speed and accuracy
- Strong interpersonal skills with high energy is required
- Demonstrated knowledge of computer and quality management systems and Microsoft Office skills required
- Working knowledge of FDA Regulations, Application of Good Laboratory Practices (GLP), Good Documentation Practices (GDP) and Good Manufacturing Practices (GMP)
- Good interpersonal/communication/written/oral skills
- Excellent oral and written communication and presentation skills (English)
4
Responsibilities For Quality Specialist Resume
- Prioritization, attention to details, multitasking and organizational skills
- Strong interpersonal and communication skills (verbal and written) to all levels of management
- Strong computer skills (MS Office, Adobe, Oracle)
- Prioritization, attention to details, multitasking, organizational skills, timeline driven and self-motivated
- Excellent communication skills and leadership within cross-functional teams
- Manufacturing experience and/or Quality Control experience in applicable field
5
Responsibilities For Quality Specialist Resume
- Auditing and Influencing Skills
- Accountable for ensuring an effective corrective /preventive plan, including verification of effective implementation
- Experience organizing and prioritizing tasks to ensure established goals and deadlines are met
- Experience in a FDA regulated environment and experience applying/interpreting required regulatory requirements
- Experience in a quality document management, quality engineering, validation, and quality assurance or quality systems
- Sound report writing, interpersonal and communication skills, both written and verbal
- Experience in a quality, manufacturing, or related operational experience
- Skilled at using appropriate quality tools and data validation
- Excellent experience in automated testing
6
Responsibilities For Quality Specialist Resume
- Proven problem-solving and root cause analysis experience
- Experience in the Pharmaceutical industry or a similar operating environment which includes experience in a Quality function
- Experience to include experience in laboratory testing
- Proficient computer skills with knowledge of computer applications related to QI, including spreadsheets
7
Responsibilities For Quality Specialist Resume
- Strong practical experience with Excel (PivotTable, Charts, Statistical functions) is required
- Execute the label/labeling change process so that only approved and validated changes are incorporated into effective product and process documentation
- Ensure Quality team are fully trained with Quality and Food Safety Standards to enable them carry out their work effectively
- English skills is communicable level
- Shop floor experience and strong technical, operations and mechanical background
- Good experience in working with Microsoft office tools
- Computer skills –Microsoft - Word, Outlook, Excel etc
- Build risk assessment/management perspective and skills
- Project Management skills and ability to use appropriate tools and resources
8
Responsibilities For Quality Specialist Resume
- Years of Experience: 1 or 2 years of experience in the Quality field
- Experience in Good Manufacturing Practice (GMP) & Food safety in a Quality related role
- Excellente experience in automated testing
- Excellent communication skill in both Chinese and English
- Proven experience in Quality improvement techniques (i.e. SixSigma, Lead Auditor)
- Good teamworker and good at communication internally and externally
- Advanced level of English skills and Fluent Polish
- Failure analysis – debug skills
- Organization and interpersonal skills required
9
Responsibilities For Quality Specialist Resume
- Overall of 6-8 year’s experience with 2-3 years functional experience in SAP Retail module
- Relevant work experience of 2 to 4 years (or equivalent combination of advanced education and relevant work experience)
- The ability to effectively present information and communicate clearly in written and oral form to all levels of management is required
- Work with limited supervision and function effectively in a team environment is essential
- Ensure that objectives are effectively achieved, consistent with MSD’s requirements to ensure compliance, safety and reliable supply to our customers
- Apply quality systems knowledge to identify, open, manage, and effectively close corrective and preventive actions
10
Responsibilities For Quality Specialist Resume
- Experience in a GMP production environment, quality control/assurance experience
- Laboratory experience or 5 years integrated healthcare experience, including 3 years hospital supervision and management
- Effectively communicate cross functionally to assist with resolving Quality issues
- Advanced ability to work in a team environment using interpersonal skills
- Prior experience working with translation services
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